Back to resultsCardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome (CTRAD)
Primary Purpose
Diabetes, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac CT
Usual medical care
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Diabetes
- Metabolic Syndrome
Exclusion Criteria:
- Symptoms of heart disease
- Heart Disease
- Renal disease
Sites / Locations
- University of California, Irvine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiac CT
Usual Care
Arm Description
Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.
Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
Outcomes
Primary Outcome Measures
Systolic BP Pressure
After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.
Secondary Outcome Measures
Full Information
NCT ID
NCT01564485
First Posted
February 24, 2012
Last Updated
June 7, 2021
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01564485
Brief Title
Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome
Acronym
CTRAD
Official Title
Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.
Detailed Description
This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Metabolic Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac CT
Arm Type
Experimental
Arm Description
Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac CT
Intervention Description
A cardiac CT involves a non-invasive test of the coronary arteries.
Intervention Type
Behavioral
Intervention Name(s)
Usual medical care
Other Intervention Name(s)
Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.
Intervention Description
Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
Primary Outcome Measure Information:
Title
Systolic BP Pressure
Description
After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.
Time Frame
Five year follow up
Other Pre-specified Outcome Measures:
Title
Change in Treatment by PCP
Description
Medication dose change or medication start/stop
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 18
Diabetes
Metabolic Syndrome
Exclusion Criteria:
Symptoms of heart disease
Heart Disease
Renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available
IPD Sharing Time Frame
Data is now available
IPD Sharing Access Criteria
We will need written request to share data
Learn more about this trial
Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome
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